csbci.com
Coastside BiotechCoastside Biotech Consultants, Inc., is a full-service Quality System and Regulatory Compliance consulting company serving domestic and international medical device manufacturers.
http://www.csbci.com/
Coastside Biotech Consultants, Inc., is a full-service Quality System and Regulatory Compliance consulting company serving domestic and international medical device manufacturers.
http://www.csbci.com/
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Contact Privacy Inc. Customer 0134757232
Contact Privacy Inc. Customer 0134757232
96 M●●●● Ave
To●●to , ON, M6K 3M1
CA
View this contact
Contact Privacy Inc. Customer 0134757232
Contact Privacy Inc. Customer 0134757232
96 M●●●● Ave
To●●to , ON, M6K 3M1
CA
View this contact
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Coastside Biotech | csbci.com Reviews
https://csbci.com
Coastside Biotech Consultants, Inc., is a full-service Quality System and Regulatory Compliance consulting company serving domestic and international medical device manufacturers.
csbci.com
Coastside Biotech
http://www.csbci.com/index.php
Areas of expertise include:. Process Development and Validation. CAPA Systems and Management. Management of Nonconforming Product. Quality System Assessment, Design, and Remediation. Industry segments served include:. MDDS (Medical Device Data Systems). E: This email address is being protected from spambots. You need JavaScript enabled to view it. FDA Statement on Medical Device User Fee Agreement (MDUFA).
Services
http://www.csbci.com/services.html
Coastside Biotech Consultants provides consulting services to medical device and diagnostics industries ranging from assessments and advice, to remediation and process improvement, to development and implementation of complete Quality Management Systems. Our primary service areas are:. Design Control development and implementation. Design History File (DHF) gap assessment and remediation of design histories and records. Integrated Medical Device Risk Management system development and implementation.
About Us
http://www.csbci.com/about-us.html
Wayne Schrier, PhD, MBA - President and Principal Consultant. Dr Schrier is a Quality System and Product Development expert with over 25 yrs of experience in the Medical Device industries. BA - Drury University (Chemistry). PhD - Texas A&M University (Biochemistry). MBA - San Jose State University. Certified Biomedical Auditor (CBA), 2010. E: This email address is being protected from spambots. You need JavaScript enabled to view it. FDA Statement on Medical Device User Fee Agreement (MDUFA).
Resources
http://www.csbci.com/resources.html
GHTF - Design Controls. GHTF - Quality Systems for Design and Manufacture of Medical Devices. GHTF - Implementattion of Risk Management Systems. GHTF - Process Validation Ed2. FDA - General Principles of Software Validation. FDA - OTS Software Guidance. FDA - Premarket Submissions for Med Devices Containing Software. FDA Guidance - Applying Human Factors and Usability to Optimize Med Device Design (draft 2011). FDA Guidance - Incorporating Human Factors Engineering into Risk Mgt.
Sample Projects
http://www.csbci.com/projects.html
Re-engineered Quality Management Systems for multiple clients to address FDA GMP and ISO compliance gaps found during internal and external audits. Implemented Quality Management System for manufacturer of Medical Device Data Systems (MDDS). Implemented corrective actions to address gaps in design control system and design history files. Corrective actions included: revising design control procedures, work instructions and forms; training management and staff; and remediating design history files. Manage...
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Soul30 - March 2018. Soul30 - March 2018. Congdon Street Baptist Church. 17 Congdon Street Providence, Rhode Island 02906. Worship every Sunday at 8:30am and 11:00am. Welcome Home to the Historic Congdon Street Baptist Church in Providence, Rhode Island. Worship Every Sunday at 8:30am and 11:00am. Pray Give. Serve. Grow. More Information about 8:30am Worship! Soul30 - March 2018 Month of Prayer. Our Pastor Justin Lester. Want to join and connect with us? Click here, we would love to reach out to you!
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Coastside Biotech
Areas of expertise include:. Process Development and Validation. CAPA Systems and Management. Management of Nonconforming Product. Quality System Assessment, Design, and Remediation. Industry segments served include:. MDDS (Medical Device Data Systems). E: This email address is being protected from spambots. You need JavaScript enabled to view it. Statement from FDA’s Donald St. Pierre on findings from ongoing investigation into lead testing issues.
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